Immunogenicity: Risk & Regulation
Immunogenicity remains a significant challenge in the development and clinical use of biologics and biosimilars. This session provides an in-depth examination of immune response mechanisms triggered by biologic therapies, including anti-drug antibody (ADA) formation and its clinical consequences. Topics include risk factors, detection methods, assay development, and predictive modeling of immunogenicity during preclinical and clinical stages. Regulatory expectations and industry best practices for immunogenicity assessment will be discussed, with an emphasis on guidance from the FDA, EMA, and WHO. The session also reviews mitigation strategies such as protein engineering, formulation optimization, and patient-specific treatment design. Real-world case studies will highlight immunogenicity concerns in therapeutic proteins, monoclonal antibodies, and biosimilar switching. This discussion is crucial for clinicians, regulatory professionals, and drug developers committed to maximizing safety and therapeutic effectiveness in biologic treatments.
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Immunogenicity: Risk & Regulation Conference Speakers
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- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
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- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Spain)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
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- Trending: Digital Health and Telemedicine for Rare Care - ORPHAN DRUGS 2025 (France)
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- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2025 (France)
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